Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial
- PMID: 33926922
- DOI: 10.1136/annrheumdis-2020-219511
Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial
Abstract
Objectives: Although causality remains to be established, targeting dysbiosis of the intestinal microbiota by faecal microbiota transplantation (FMT) has been proposed as a novel treatment for inflammatory diseases. In this exploratory, proof-of-concept study, we evaluated the safety and efficacy of FMT in psoriatic arthritis (PsA).
Methods: In this double-blind, parallel-group, placebo-controlled, superiority trial, we randomly allocated (1:1) adults with active peripheral PsA (≥3 swollen joints) despite ongoing treatment with methotrexate to one gastroscopic-guided FMT or sham transplantation into the duodenum. Safety was monitored throughout the trial. The primary efficacy endpoint was the proportion of participants experiencing treatment failure (ie, needing treatment intensification) through 26 weeks. Key secondary endpoints were change in Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR20) response at week 26.
Results: Of 97 screened, 31 (32%) underwent randomisation (15 allocated to FMT) and 30 (97%) completed the 26-week clinical evaluation. No serious adverse events were observed. Treatment failure occurred more frequently in the FMT group than in the sham group (9 (60%) vs 3 (19%); risk ratio, 3.20; 95% CI 1.06 to 9.62; p=0.018). Improvement in HAQ-DI differed between groups (0.07 vs 0.30) by 0.23 points (95% CI 0.02 to 0.44; p=0.031) in favour of sham. There was no difference in the proportion of ACR20 responders between groups (7 of 15 (47%) vs 8 of 16 (50%)).
Conclusions: In this first preliminary, interventional randomised controlled trial of FMT in immune-mediated arthritis, we did not observe any serious adverse events. Overall, FMT appeared to be inferior to sham in treating active peripheral PsA.
Trial registration number: NCT03058900.
Keywords: arthritis; inflammation; psoriatic; therapeutics.
© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Conflict of interest statement
Competing interests: VA declares personal fees from Merck (MSD) and personal fees from Janssen, outside the submitted work. RC declares a core grant to his institution (Parker Institute, Bispebjerg and Frederiksberg Hospital) from the Oak Foundation (OCAY-18-774-OFIL) and honorariums paid to his institution in relation to the following activities: lecture, research methods (Pfizer, DK; 2017); lecture, GRADE lecture (Celgene, DK; 2017); ad board lecture, CAM (Orkla Health, DK; 2017); project grant: 'GreenWhistle' (Mundipharma, 2019); lecture: diet in RMD (Novartis, DK; 2019); consultancy report, Network MA’s (Biogen, DK; 2017); ad board lecture, GRADE (Lilly, DK; 2017); consultancy report, GRADE (Celgene, 2018); and lecture, Network MA’s (LEO; 2020).
Comment in
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Correspondence on 'Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial'.Ann Rheum Dis. 2023 Jul;82(7):e164. doi: 10.1136/annrheumdis-2021-220871. Epub 2021 Jun 22. Ann Rheum Dis. 2023. PMID: 34158372 No abstract available.
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